The Powerhouse for Anti-infectives –
Committed to making the difference
AiCuris is a pharmaceutical company specializing in the discovery, research, and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies which has brought a drug with “block buster” potential to the market (Prevymis® 2017/18).
AiCuris is offering the position of a:
CMC Expert, Biologicals (m/f/d)
(in full time)
Reporting to the Head of Chemistry, Pharmaceutical Development and Patent Affairs
In this role you will be responsible for the co-ordination of all CMC activities (outsourcing) for all the AiCuris biological development projects.
- To support development and subsequent manufacturing of biological processes from cell line development through upstream and downstream processing
- Conceptualize and lead early and late stage formulation development (liquid, lyophilized, high concentration etc.) for macromolecules (Proteins and antibodies)
- Develop and optimize processes for drug substance
- Manage activities relevant to drug product development (mixing studies, filtration studies, extractable/leachable studies etc.)
- Responsible for technology transfer from the early stage CROs to late stage CMOs during different phases of product development
- Actively contribute to relevant part of CTD section 3 of IND/IMPD’s.
- Interpret and report results of work carried out in written and verbal format performed with external partners
- Evaluate external developments in the area of drug substance manufacturing and formulation development
Skills and qualification
- PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3-5 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 8 years industrial experience
- Significant experience in protein/monoclonal antibodies/bispecifics formulation for both early and late phase development
- Experience in process development related to drug substance and drug products (lyophilization) manufacturing
- Knowledge of technology transfer and regulatory submissions in USA/EU for sections relevant to drug product development/manufacturing
- Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment)
- Ability to manage development and manufacturing with external partners
- Experience in regulatory relationships (scientific advices)
- Fluency in English, both written and verbal
- Excellent communication skills and strong diplomacy skills required
What we can offer
- Cooperation in multinational and interdisciplinary teams
- An exciting and challenging job in a promising research and development company with an excellent R&D portfolio
- Flexible working hours and self-determined time management
- Regular and targeted further training and individual development opportunities
- Attractive company pension scheme
- A wide range of services relating to health and reconciling work and family life
How to apply
You can find a PDF of the job description here.
Interested to join our team?
If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.
Note for headhunters: We are not interested in support. Thanks!
AiCuris Anti-infective Cures AG
Friedrich-Ebert-Str. 475 / Build. 302